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Selling cosmetics in Brazil

In Brazil, personal hygiene products, cosmetics and perfumes follow ANVISA's RDC 907/2024. Products are Grade 1 or Grade 2 by risk; nine groups, including sunscreens, repellents and hair straighteners, need registration, and the rest are communicated to ANVISA before sale. The company needs ANVISA authorisation, and labels are in Brazilian Portuguese.

Updated · Each section links to the official source it comes from

Regulator
ANVISA
Main rule
RDC 907/2024, as amended by RDC 949/2024
Risk grades
Grade 1 and Grade 2 (Annex I)
Before sale
Registration for nine groups; prior communication for the rest
Company
ANVISA operating authorisation (AFE) and local licence
Label language
Brazilian Portuguese, except INCI names, name and brand

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is the product a cosmetic under RDC 907/2024, and is it Grade 1 or Grade 2? Read more
  2. 2Does its group need registration, or prior communication? Read more
  3. 3Does the company hold an ANVISA operating authorisation (AFE)? Read more
  4. 4Are the ingredients within the ANVISA lists? Read more
  5. 5What must the label show, in Brazilian Portuguese? Read more
  6. 6How are adverse reactions monitored? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Scope and risk grades

What counts as a personal hygiene product, cosmetic or perfume, and how it is graded.

  • These are preparations of natural or synthetic substances for external use on the body, to clean, perfume, change appearance, correct body odours or protect it (RDC 907/2024, Article 3).
  • By area of application, intended users, formulation or the health impact of the declared uses, Grade 1 products initially need a lower degree of health surveillance and Grade 2 products a greater one (Article 3, with indicative lists in Annex I).
  • Grade 2 includes sunscreens, children's products, antiperspirants, hair dyes and straighteners, repellents, and anti-acne and anti-dandruff products (ANVISA cosmetics FAQ).
  • RDC 907/2024 replaced RDC 752/2022 and incorporates Mercosur resolutions.

How we help: Compliant Always keeps the grading for each product and the evidence behind it, so the answer is on record when a retailer asks. Ask about this

Registration, communication and company authorisation

How a product is put on record with ANVISA, and what the company needs first.

  • Nine groups need registration: tanning products, antiseptic hand gel, hair straighteners, straighten-and-dye products, hair waving products, sunscreen, children's sunscreen, insect repellent and children's insect repellent (Article 34).
  • Other groups are exempt from registration and are communicated to ANVISA before sale (comunicação prévia) (Article 35).
  • Regularisation is filed online (Article 32); a registration is valid for 10 years from publication in the official gazette (Article 40).
  • Manufacturers and importers need an ANVISA operating authorisation (Autorização de Funcionamento de Empresa, AFE) for the product class and a licence from the local health authority (Articles 37 and 38).
  • Good manufacturing practice is checked by inspection of the producer or importer (Article 39).

How we help: Compliant Always keeps the AFE, the registration or communication and its number with each product, and shows when a renewal window opens. Ask about this

Ingredients and safety file

The ANVISA lists ingredients must meet, and what the company keeps on file.

  • Products follow the ANVISA lists: prohibited substances (RDC 529/2021), restricted substances (RDC 530/2021 and RDC 645/2022), preservatives (RDC 528/2021), colourants (RDC 628/2022), UV filters (RDC 600/2022) and hair straightener actives (IN 220/2023) (Article 6).
  • The holder keeps data on quality, safety and efficacy, and signs a statement of responsibility (Termo de Responsabilidade) (Article 5).
  • Kept on file: efficacy and safety data, stability, specifications, the manufacturing process and lot coding (Article 9).

How we help: Upload a formula and Compliant Always reads each ingredient against the ANVISA lists, and keeps the safety and stability data with the product. Ask about this

Labelling

What the primary and secondary packs must show.

  • The primary pack shows warnings, the product group, the lot, the brand and the name (Article 13).
  • The secondary pack also shows contents, a consumer contact, the regularisation process number, the AFE number, the CNPJ and name of the holder, the ingredients by INCI name, the country of origin and the expiry date (Article 13).
  • Mandatory information is legible in Brazilian Portuguese, except INCI names, the product name and brands (Article 20).
  • Imported products may be adapted with a sticker (Article 21), and may not claim therapeutic action, in any language (Article 22).

How we help: Compliant Always reads your primary and secondary pack artwork against the Article 13 particulars, and shows which item is missing. Ask about this

Cosmetovigilance and enforcement

What happens after the product is on sale.

  • Cosmetovigilance monitors adverse reactions after sale, coordinated by ANVISA with state and municipal health surveillance (ANVISA cosmetovigilance page).
  • A breach of RDC 907/2024 can lead to cancellation of the product's regularisation (Article 45), and breaches of health law are infractions under Law 6.437/1977.

How we help: Compliant Always ties each complaint and document to the product and lot, so a reaction report can be traced to the batch. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Holder (detentor)The regularisation, the safety and efficacy data and the statement of responsibility.The safety file, filings and labels kept together, by product and lot.
ManufacturerThe AFE, local licence and good manufacturing practice.Specifications, stability data and lot coding kept with each product.
ImporterThe AFE for import, the Portuguese label or sticker, and no therapeutic claims.The foreign supplier's documents read and dated before the goods arrive.
RetailerSelling regularised products.Questionnaires answered from the record of each product.

States and municipalities

Under the Consumer Defence Code, the federal government, the states and the Federal District make concurrent rules on production, distribution and consumption, and together with the municipalities they oversee and control production, distribution and advertising (Article 55).

Health surveillance is shared: state, Federal District and municipal health authorities license food establishments and receive the communication of start of manufacture for many foods, and INMETRO's delegated state bodies (IPEMs) inspect regulated and pre-packaged products on the market.

Questions businesses ask

Do I need to register my cosmetics in Brazil?
Only nine groups need registration: tanning products, antiseptic hand gel, hair straighteners and waving products, sunscreens and insect repellents, including children's versions. Other cosmetics are exempt and are communicated to ANVISA before sale (RDC 907/2024, Articles 34 and 35).
What is the difference between Grade 1 and Grade 2 cosmetics?
Grade 1 products initially need a lower degree of health surveillance and Grade 2 products a greater one, judged by area of application, users, formulation and declared uses. Grade 2 includes sunscreens, children's products, antiperspirants and hair dyes (RDC 907/2024, Article 3 and Annex I).
Does a Grade 2 cosmetic always need registration?
No. Registration depends on the product group in Article 34 of RDC 907/2024, not on the grade alone. A Grade 2 product outside those nine groups is communicated to ANVISA.
Which ANVISA rule replaced RDC 752/2022?
RDC 907 of 19 September 2024, amended by RDC 949/2024, on personal hygiene products, cosmetics and perfumes.
What is an AFE?
The ANVISA operating authorisation (Autorização de Funcionamento de Empresa). Companies that make or import cosmetics need one for the product class, plus a local health licence (RDC 907/2024, Articles 37 and 38).
Do cosmetic labels have to be in Portuguese?
Yes, in Brazilian Portuguese, except INCI ingredient names, the product name and brands (RDC 907/2024, Article 20). Imports may add a sticker (Article 21).
What goes on the outer pack of a cosmetic in Brazil?
Contents, a consumer contact, the regularisation number, the AFE number, the holder's name and CNPJ, INCI ingredients, country of origin and expiry, as well as warnings, group, lot, brand and name (RDC 907/2024, Article 13).
How long is a cosmetic registration valid in Brazil?
Ten years from publication in the official gazette, renewable (RDC 907/2024, Article 40). Exempt products are not revalidated.
Which ingredient lists apply to cosmetics in Brazil?
Prohibited (RDC 529/2021), restricted (RDC 530/2021 and RDC 645/2022), preservatives (RDC 528/2021), colourants (RDC 628/2022), UV filters (RDC 600/2022) and straightener actives (IN 220/2023).
Can an imported cosmetic make therapeutic claims?
No. Imported products may not claim therapeutic action or carry prohibited or unproven statements, whatever the label's language (RDC 907/2024, Article 22).
How does Compliant Always help with selling in Brazil?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Brazil and what your paperwork needs to show.

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